Welcome to our dedicated page for Neurocrine Biosciences news (Ticker: NBIX), a resource for investors and traders seeking the latest updates and insights on Neurocrine Biosciences stock.
Neurocrine Biosciences Inc (Nasdaq: NBIX) is a neuroscience-focused biopharmaceutical company whose news flow centers on clinical data, product performance and pipeline progress in movement disorders, neuropsychiatry, endocrinology and metabolic disease. The company regularly issues updates on its flagship VMAT2 inhibitor INGREZZA (valbenazine) for tardive dyskinesia and chorea associated with Huntington’s disease, including head-to-head pharmacologic studies, long-term efficacy analyses and peer-reviewed publications.
NBIX news commonly features clinical trial readouts across its pipeline. Recent releases have covered Phase 3 and Phase 4 data for INGREZZA in tardive dyskinesia and Huntington’s disease chorea, a Phase 3 study of valbenazine in dyskinetic cerebral palsy, and Phase 2 results for investigational compounds such as NBI-1070770 in major depressive disorder. Investors and clinicians can also follow updates on late-stage programs including osavampator for major depressive disorder and direclidine for schizophrenia and bipolar mania, as well as next-generation VMAT2 inhibitors and CRF-based therapies for metabolic diseases like obesity.
Another major theme in Neurocrine Biosciences news is financial and corporate reporting. The company announces quarterly net product sales for INGREZZA and CRENESSITY, provides guidance ranges for research and development and selling, general and administrative expenses, and discusses its R&D strategy at events such as its annual R&D Day and healthcare investor conferences. Management presentations at large industry meetings, including the J.P. Morgan Healthcare Conference and other investor conferences, are also highlighted in press releases.
This NBIX news page aggregates these updates so readers can quickly review earnings announcements, clinical milestones, R&D strategy briefings, investor conference appearances and key scientific publications related to Neurocrine Biosciences. For anyone tracking developments in tardive dyskinesia, Huntington’s disease chorea, classic congenital adrenal hyperplasia, neuropsychiatric disorders or emerging CRF-based metabolic therapies, the news stream provides a concise view of the company’s ongoing activities and disclosures.
Neurocrine Biosciences reported third-quarter 2022 net product sales of $376 million for INGREZZA, a 31% year-over-year increase.
The company raised its 2022 guidance for INGREZZA net sales to between $1.4 billion and $1.425 billion.
An sNDA for valbenazine to treat chorea in Huntington Disease was submitted to the FDA, expanding its therapeutic reach.
GAAP net income rose to $68.5 million or $0.69 per diluted share, reflecting strong performance driven by an expanding patient base and recent sales force enhancements.
Neurocrine Biosciences (Nasdaq: NBIX) has initiated a Phase 2 clinical study for NBI-1117568, a first-in-class muscarinic M4 selective agonist targeting adults with schizophrenia. The study will enroll about 200 patients across 15 U.S. sites, assessing efficacy and safety using the Positive and Negative Syndrome Scale (PANSS). NBI-1117568 aims to provide an improved safety profile and potentially different side effects compared to traditional antipsychotics, addressing a condition that affects approximately 20 million people worldwide.
Neurocrine Biosciences (NASDAQ: NBIX) presented the baseline characteristics of Parkinson's disease patients in the Opicapone Treatment Initiation Open-Label Study (OPTI-ON) at ANA2022. The study included 239 participants across 30 U.S. sites, focusing on the use of ONGENTYS as an adjunct treatment to carbidopa/levodopa. The mean age of participants was 67.7 years with a mean Parkinson's duration of 8.6 years. Findings will assess treatment patterns and safety, complementing data from pivotal trials. ONGENTYS, approved in April 2020, helps increase levodopa availability for better treatment outcomes.
On October 19, 2022, Neurocrine Biosciences (Nasdaq: NBIX) presented a retrospective study on the use of benztropine among patients prescribed antipsychotic medications at the 2022 APNA Annual Conference. The study analyzed data from January 2017 to March 2020, revealing significant polypharmacy in patients prescribed benztropine. Key findings indicated that 38% of patients used benztropine for over six months, suggesting a need for better management of anticholinergic medications. The Chief Medical Officer emphasized that while benztropine aids in acute treatment, it is not suitable for tardive dyskinesia.
Neurocrine Biosciences (Nasdaq: NBIX) will host its third quarter 2022 financial results conference call and webcast on November 1, 2022, at 5:00 a.m. PT (8:00 a.m. ET). The Q3 press release will be available earlier on the same day at 4:30 a.m. PT (7:30 a.m. ET). Investors can access the call via domestic 866-952-8559 or international 785-424-1881 dial-in numbers using conference ID NBIX. A replay will be available on the company’s website.
Neurocrine focuses on treatments for neurological and psychiatric disorders.
Neurocrine Biosciences (NASDAQ: NBIX) announced the appointment of Dr. Ingrid Delaet as its Chief Regulatory Officer, effective October 1, 2022. Dr. Delaet, previously the Vice President of Regulatory Affairs at Neurocrine since January 2021, will oversee regulatory affairs, quality assurance, medical writing, and program management. Her extensive background includes senior roles at Intercept Pharmaceuticals and Bristol-Myers Squibb. CEO Kevin Gorman noted her experience will significantly contribute to the company's goal of developing innovative treatments for neurological and neuropsychiatric disorders.
On September 19, 2022, Neurocrine Biosciences (Nasdaq: NBIX) shared data at the Psych Congress 2022, showcasing the long-term efficacy of INGREZZA (valbenazine) in treating tardive dyskinesia (TD). The post hoc analysis from the KINECT 4 study revealed that patients' response rates to treatment increased significantly over 48 weeks. Specifically, AIMS improvement rates rose from 39% at week 8 to 86% at week 48. Adverse events were mainly urinary tract infections (8.5%) and headaches (5.2%). This data underscores INGREZZA's lasting benefits for patients suffering from TD.
Neurocrine Biosciences (NASDAQ: NBIX) announced survey findings highlighting the need for enhanced education on managing tardive dyskinesia (TD) symptoms. The data, presented at the MDS International Congress from September 15-18, 2022, in Madrid, revealed that the prevalence of TD is often underestimated. Key findings include an increase in clinicians opting for pharmacologic therapies and acknowledging patient complaints regarding social anxiety. The company emphasizes the importance of managing TD while addressing underlying psychiatric disorders.
On September 15, 2022, Neurocrine Biosciences presented data on ONGENTYS® (opicapone) at the MDS International Congress in Madrid, Spain. The findings indicate that a once-daily 50 mg dose of ONGENTYS alongside levodopa/carbidopa can reduce soluble-catechol-O-methyltransferase (S-COMT) activity by over 80%, leading to more consistent levodopa exposure in Parkinson’s disease patients. The analysis was based on two previous Phase 1 studies, showcasing significant reductions in S-COMT variability. Survey results on clinician education needs in managing Parkinson’s OFF episodes were also discussed.
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